Website Application Based Education and Text Messaging in Improving Skin Wound Care in Patients Undergoing Mohs Surgery

NCT ID: NCT02373722

Last Updated: 2018-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

90 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-03-31

Brief Summary

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This randomized clinical trial studies how well website application (web app) based education and text messaging works in improving skin wound care in patients undergoing Mohs surgery (a surgical procedure used to treat skin cancer). Website application and text messaging based education may help patients stick to wound care instructions before and after surgery, lower anxiety level, and may help monitor their activity.

Detailed Description

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PRIMARY OBJECTIVES:

I. To create a web application which will educate dermatologic surgery patients prior to their operations with educational videos.

SECONDARY OBJECTIVES:

I. To create and evaluate a web based system to send wound care instructions to patients by text message after their operation.

II. Qualitative comments from participants and research staff concerning the feasibility of this approach and the use of Fitbit activity trackers as a means to monitor movement restriction.

III. The rate of adverse events.

OUTLINE: Patients are randomized to 1 of 4 groups.

GROUP I: Patients watch an educational video about Mohs surgery before their surgery, a video about wound care after the surgery and receive text messages about wound care on days 1-5 after the surgery. Patients also receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are instructed to apply petroleum jelly twice daily (BID) to the wound area.

GROUP II: Patients watch an educational video about Mohs surgery before their surgery, an educational video about wound care after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients apply petroleum jelly BID to the wound area.

GROUP III: Patients receive text messages about wound care on days 1-5 after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound are.

GROUP IV: Patients receive no video or text messages. Patients receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound area.

After completion of study, patients are followed up at 1 week.

Conditions

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Malignant Skin Neoplasm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Investigators

Study Groups

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Group I (video, text message)

Patients watch an educational video about Mohs surgery before their surgery, a video about wound care after the surgery and receive text messages about wound care on days 1-5 after the surgery. Patients also receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are instructed to apply petroleum jelly BID to the wound area.

Group Type EXPERIMENTAL

Mohs Surgery

Intervention Type PROCEDURE

Undergo Mohs surgery

Internet-Based Intervention

Intervention Type OTHER

Watch website application based educational video

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Receive text messages

Educational Intervention

Intervention Type OTHER

Watch website application based educational video

Exercise Intervention

Intervention Type BEHAVIORAL

Use Fitbit

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Intervention Type OTHER

Applied to the wound area

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Group II (educational video)

Patients watch an educational video about Mohs surgery before their surgery, an educational video about wound care after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients apply petroleum jelly BID to the wound area

Group Type EXPERIMENTAL

Mohs Surgery

Intervention Type PROCEDURE

Undergo Mohs surgery

Internet-Based Intervention

Intervention Type OTHER

Watch website application based educational video

Educational Intervention

Intervention Type OTHER

Watch website application based educational video

Exercise Intervention

Intervention Type BEHAVIORAL

Use Fitbit

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Intervention Type OTHER

Applied to the wound area

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Group III (text message)

Patients receive text messages about wound care on days 1-5 after the surgery and receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound are.

Group Type EXPERIMENTAL

Mohs Surgery

Intervention Type PROCEDURE

Undergo Mohs surgery

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Receive text messages

Exercise Intervention

Intervention Type BEHAVIORAL

Use Fitbit

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Intervention Type OTHER

Applied to the wound area

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Group IV (control)

Patients receive no video or text messages. Patients receive instructions to reduce movement and use a Fitbit activity tracker. Beginning 48 hours after surgery, patients are also instructed to apply petroleum jelly BID to the wound area.

Group Type EXPERIMENTAL

Mohs Surgery

Intervention Type PROCEDURE

Undergo Mohs surgery

Exercise Intervention

Intervention Type BEHAVIORAL

Use Fitbit

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Intervention Type OTHER

Applied to the wound area

Questionnaire Administration

Intervention Type OTHER

Ancillary studies

Survey Administration

Intervention Type OTHER

Ancillary studies

Interventions

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Mohs Surgery

Undergo Mohs surgery

Intervention Type PROCEDURE

Internet-Based Intervention

Watch website application based educational video

Intervention Type OTHER

Telephone-Based Intervention

Receive text messages

Intervention Type BEHAVIORAL

Educational Intervention

Watch website application based educational video

Intervention Type OTHER

Exercise Intervention

Use Fitbit

Intervention Type BEHAVIORAL

Petrolatum-Mineral Oil-Lanolin-Ceresin Ointment

Applied to the wound area

Intervention Type OTHER

Questionnaire Administration

Ancillary studies

Intervention Type OTHER

Survey Administration

Ancillary studies

Intervention Type OTHER

Other Intervention Names

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Education for Intervention Intervention, Educational Aquaphor

Eligibility Criteria

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Inclusion Criteria

* The patient is undergoing Mohs surgery
* Subject is capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed
* The subject is able to complete the study and comply with study instructions, including attending all study visits
* The patient has a cell phone capable of receiving text messages

Exclusion Criteria

* The patient is not indicated for Mohs surgery
* Inability to complete all study-related visits
* Non-English speaking patients
* The patient cannot receive text messages
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel Pearce

Role: PRINCIPAL_INVESTIGATOR

Wake Forest University Health Sciences

Locations

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Comprehensive Cancer Center of Wake Forest University

Winston-Salem, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2015-00217

Identifier Type: REGISTRY

Identifier Source: secondary_id

CCCWFU 01714

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00028840

Identifier Type: -

Identifier Source: org_study_id

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